BUSCOPAN 10 MG COATED TABLETS 40 TABLETS IN AL/PVC BLISTER

Name
BUSCOPAN 10 mg coated tablets
BUSCOPAN 10 mg suppositories
N-butyl hyoscine bromide


What is it and what is it used for?
Buscopan contains the active substance hyoscine N-butylbromide, which belongs to a group of medicines called semi-synthetic belladonna alkaloids used for motility disorders of the stomach, intestine and biliary tract (gastrointestinal tract).
Buscopan is indicated in adults and children over 6 years of age for:
• pain and spasms in the stomach and intestines;
• pain and spasms due to obstacles in the flow of the bile ducts (where bile, a substance involved in some digestive processes, flows).

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


What you need to know before taking the medicine
Do not take Buscopan
• if you are allergic to the active substance hyoscine N-butylbromide or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle glaucoma);
• if you suffer from an enlarged prostate (prostatic hypertrophy);
• if you suffer from an inability of the urinary bladder to empty completely (urinary retention);
• if you suffer from narrowing of the pylorus, the terminal part of the stomach (pyloric stenosis) or narrowing of other areas of the stomach and intestine (stenosis of other parts of the gastrointestinal tract);
• if you have intestinal blockage or suspect you have intestinal blockage;
• if you suffer from bowel disease associated with disturbances in bowel movements (paralytic or obstructive ileus), chronic inflammatory bowel disease (ulcerative colitis) and dilation of the colon (megacolon);
• if you suffer from a disorder caused by frequent regurgitation of stomach contents into the oesophagus, the tube through which food reaches the stomach (reflux oesophagitis);
• if you are elderly or if your physical condition is weak and you suffer from lack of bowel movements, which causes intestinal obstruction (intestinal atony);
• if you suffer from muscle weakness (myasthenia gravis);
• in children under 6 years of age;
• in case of rare hereditary conditions which may be incompatible with an excipient of the product (see "Buscopan coated tablets contain sucrose").


Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Contact your doctor immediately if you experience severe pain in the stomach area (abdominal pain), for no apparent reason, that persists or worsens, or is accompanied by symptoms such as fever, nausea, vomiting, disturbed bowel movements, intestinal tenderness, low blood pressure, fainting, or blood in the stool.

Use Buscopan with caution :
• if he is elderly;
• if you suffer from a disorder of the nerves that control the correct functioning of glands and organs (autonomic nervous system);
• if you suffer from or are predisposed to heart rhythm disorders (cardiac tachyarrhythmias);
• if you suffer from high blood pressure (arterial hypertension);
• if your heart does not have sufficient and adequate strength to pump blood around the body (congestive heart failure);
• if you suffer from an alteration in the functioning of the thyroid which can lead to weight loss, tiredness, weakness (hyperthyroidism);
• if you suffer from liver and/or kidney disease;
• if you are predisposed to a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle glaucoma);
• if you are predisposed to intestinal and urinary tract obstruction (intestinal and urinary stasis);
• if he has a fever.

Medicines such as Buscopan can prolong the stomach emptying time with stagnation of substances.
Do not suddenly stop treatment with high doses. Your doctor will adjust the dose to control mild side effects or discontinue treatment if severe side effects occur.

Children and adolescents
Buscopan should not be given to children under 6 years of age.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are listed below according to the following frequency:

Uncommon (may affect up to 1 in 100 people)
• skin reactions (skin reactions),
• appearance of wheals accompanied by itching (urticaria),
• itching,
• increased number of heartbeats per minute (tachycardia),
• dry mouth,
• changes in sweating.

Rare (may affect up to 1 in 1,000 people)
• inability of the urinary bladder to empty completely (urinary retention).

Frequency not known (frequency cannot be estimated from the available data)
• severe allergic reactions (anaphylactic reactions up to anaphylactic shock),
• difficulty breathing (dyspnea),
• skin rash,
• skin irritation (erythema) and other allergic manifestations.

The following side effects have also been observed:
• dilation of the pupil (mydriasis),
• difficulty focusing images (accommodation disorders),
• increased pressure of the fluid contained in the eye (ocular pressure),
• drowsiness,
• constipation.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.